AQA Associate III MDI

Job Title: AQA Associate III

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General: 8:30 AM – 5:00 PM (may vary based on business needs)

Reports To: AQA Supervisor

Salary Range: $86,000 - $95,000

This position requires a strong analytical chemistry/lab background and experience.

• Reviewing and confirming compliance related to raw materials, in‑process and finished product analytical documents.
• Monitoring and ensuring cGLP followed by laboratory personnel during routine operation to ensure adherence to procedures.
• Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance.
• Verifying the laboratory chemicals/reagents, standards for completeness of the labels against SOPs.
• Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Review of laboratory audit trials during data review against SOPs.
• Coordinating with the Analytical Laboratory Teams to arrange required documents to cross‑functional teams.
• Maintaining all incoming documents with proper tracking, recording, storage and archival.
• Reviewing and identifying gaps within the system during routine monitoring and informing the supervisor of necessary improvements.
• Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.
• Performing other departmental and cross‑functional projects and assignments given by the manager/supervisor.

• Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master’s degree preferred.
• A minimum of 5‑8 years in analytical (preferably in analytical quality assurance for minimum of 3 years).
• Must be proficient in computer skills and software applications such as Microsoft Office tools and quality applications and software programs.
• Strong knowledge and experience with analytical laboratory activities in areas such as API, drug products, analytical development, QC, GLP/GMP/GDP, USP monograph requirements.

• Understanding of laboratory equipment operation, qualification and calibrations including their software audit trial reviews (e.g., HPLC, UV‑Vis spectrophotometer, GC, potentiometer, pH meter, stability chambers).
• Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Experience in inhalation products (MDI/DPI) is a plus.
• Ability to work in a fast‑paced, dynamic environment within a manufacturing operation setting.
• Must communicate clearly and concisely across all levels of the organization and possess solid command of English language skills (verbal, written, interpersonal).
• Must possess strong documentation and technical writing skills, and apply relevant scientific principles and practices.
• Must work under minimal supervision and act independently in a team environment.

• Proficiently speak English as a first or second language and ability to read, write and communicate effectively.
• Must be a self‑starter and demonstrate initiative to seek additional training or direction when needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday‑Friday.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Self‑motivated, able to work in a fast‑paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills and ability to focus on details.

• General shift but must be willing and able to work any assigned first or second shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or a combination based on business needs.
• May be required to work some weekends based on business needs as directed by management.
• Relocation negotiable.
• No remote work available.
• This role works in cGMP laboratory or manufacturing environment where PPE is required (uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.).
• Weekend or holiday work may be requested or required based on business needs.

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.